Kidney Function in Obese Women

NCT06905236 | Completed DMC

• 1 other identifier: Training and kidney
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the impact of a 10-week moderate intensity interval walking training (MIIWT) program on kidney function markers in obese postmenopausal women. The main question it aims to answer is: Does MIIWT improve kidney function markers in this population? Researchers will compare MIIWT (designed to training group) to non-training intervention (designed to control group) to see if the training program works to improve kidney function markers. Participants in training group will: perform a 10-week MIIWT program, four sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). Participants in control group will : not perform any physical training and maintain their usual daily activities.

Conditions

Kidney Function Tests

Keywords

Glomerular Filtration Rate; neutrophils; obesity; serum creatinine; walking training; white blood cells

Outcome Measures

Primary Outcomes (10)

• serum creatinine

  serum concentrations of creatinine (sCr) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).

  At baseline and at week 11(after the ten weeks of the training intervention).

• blood urea nitrogen

  serum concentrations of blood urea nitrogen (BUN) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).

  At baseline and at week 11(after the ten weeks of the training intervention).

• serum uric acid

  serum concentrations of uric acid (sUA) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).

  At baseline and at week 11(after the ten weeks of the training intervention).

• glomerular Filtration Rate

  the glomerular Filtration Rate (GFR) has been computed using the Cockcroft formula, as follows: GFR (mL/min) = \[(140 - age) × weight ×0.85\]/(sCr× 72).

  At baseline and at week 11(after the ten weeks of the training intervention).

• white blood cells count

  blood concentration of white blood cells (WBC) count were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany)

  At baseline and at week 11(after the ten weeks of the training intervention).

• neutrophils

  blood concentration of neutrophils (NEU) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).

  At baseline and at week 11(after the ten weeks of the training intervention).

• lymphocytes

  blood concentrations of lymphocytes (LYM) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).

  At baseline and at week 11(after the ten weeks of the training intervention).

• monocytes

  blood concentration of monocytes (MON) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).

  At baseline and at week 11(after the ten weeks of the training intervention).

• eosinophils

  blood concentrations of eosinophils (EOSI) ) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).

  At baseline and at week 11(after the ten weeks of the training intervention).

• basophils

  blood concentration of basophils (BASO) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).

  At baseline and at week 11(after the ten weeks of the training intervention).

Secondary Outcomes (2)

• Body composition

  At baseline and after ten weeks of the training intervention.

• 6 min walking test

  At baseline and after ten weeks of the training intervention.

Study Arms (2)

Training group

EXPERIMENTAL

The training group underwent a moderate intensity intermittent walking training at 60% to 80% of the 6- min-walking-test distance, four times a week of 60 min/session for a period of 10 weeks.

Behavioral: walking intervention

Control group

NO INTERVENTION

No training intervention was intended for the control group.

Interventions

walking intervention BEHAVIORAL

Moderate intensity intermittent walking training for a period of 10 weeks. The intensity of the training is 60 to 80% of 6MWTdistance. The frequency of the training is four times a week.

Training group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• be aged between 50 and 60 years.
• be postmenopausal (absence of menses \> 12 months).
• present a BMI greater than or equal to 30 kg/m2.
• be free of any special diets in the three months prior to the start of the intervention.
• have a sedentary lifestyle (exercise less than 2 h/week).

You may not qualify if:

• Suffering from any cardiovascular/renal/pulmonary/metabolic disease.
• Being under menopausal hormone therapy.
• Presenting any orthopedic limitations interfering the ability to perform the study intervention.

Sponsors & Collaborators

• Wissal Abassi: lead

Study Sites (1)

High Institute of Sports and Physical Education of Kef

Boulifa, Kef Governorate, 7100, Tunisia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: September 23, 2024
• Primary Completion: December 22, 2024
• Study Completion: December 22, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)